Catalog Number

-

Brand Name

Ecogel 200

Version/Model Number

40JBC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

4551933b-57f5-4fdc-8c27-4a1568ef32d9

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 23, 2016

Package DI Number

00628055650720

Quantity per Package

12

Contains DI Package

00628055650614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case